Overview

This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Treatment abt-199
Phase phase 1
Target BCL-2
Sponsor AbbVie
Collaborator Genentech, Inc.
Start date December 2013
End date July 2018
Trial size 28 participants
Trial identifier NCT01969695, M13-835

Summary

This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's lymphoma (NHL) (excluding chronic lymphocytic lymphoma [CLL], small lymphocytic lymphoma [SLL], and mantle cell lymphoma [MCL]) who completed a prior ABT-199 study, or were active and assigned to ABT-199 when the study was completed, may roll over into this extension study. Subjects will receive ABT-199 during this study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ABT-199 monotherapy
abt-199 GDC-0199
ABT-199 continuous once daily dosing

Primary Outcomes

Measure
Number of subjects with adverse events
time frame: Measured up to 2 years after the last subject has enrolled in the study
Percentage of subjects with adverse events
time frame: Measured up to 2 years after the last subject has enrolled in the study
Change in physical exam finding, including vital signs
time frame: Measured from Day 1 up to 2 years after the last subject has enrolled in the study
Change in clinical laboratory test results
time frame: Measured from Day 1 up to 2 years after the last subject has enrolled in the study
Change in cardiac assessment findings
time frame: Measured from Day 1 up to 2 years after the last subject has enrolled in the study

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Subject has completed a prior ABT-199 study (and had met the criteria for a diagnosis of NHL and all other eligibility criteria for the previous study) and the investigator believes that treatment with ABT-199 is in the best interest of the subject. Exclusion Criteria: - Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other). - Subject has any medical condition that in the opinion of the investigator places the subject at an unacceptably high risk for toxicities. - Subject has not recovered to ≤ Grade 2 clinically significant adverse effect(s)/toxicity(ies) of previous therapy. - Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL).

Additional Information

Official title An Extension Study of Venetoclax in Subjects With Advanced Non-Hodgkin's Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.